K242006 is an FDA 510(k) clearance for the SureWave Elastography (Q7000225). This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Quality Electrodynamics, LLC (Mayfield Heights, US). The FDA issued a Cleared decision on February 12, 2025, 218 days after receiving the submission on July 9, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K242006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2024 |
| Decision Date | February 12, 2025 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNH — System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |